MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 2 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422352

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that, after a right medial unicompartmental knee replacement had been performed on an unspecified date to address osteoarthritis symptoms, the patient required a conversion to tka on an unknown date due to unspecified complications and/or adverse events.According to the data set provided, this event occurred forty four (44) months following the index implantation.The outcome of this patient is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a right revision/conversion to total knee arthroplasty was performed approximately 44 months post implantation due to unspecified complications and/or adverse events.Reportedly, the anonymized data collection activity was performed retrospectively; therefore, the information provided may be limited in detail and lack the ability for additional due diligence.As of the date of this medical investigation, patient specific medical documentation has not been provided and definitive clinical factors which could have contributed to the reported event could not be concluded.The patient impact beyond that which was reported (revision/conversion to total knee arthroplasty) could not be determined.The current health status is unknown.No further medical assessment can be rendered at this time.Devices batch number were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed devices.A review of the instructions for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this products and events.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H11: the results of investigation were corrected.Please read the corrected version below.The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a right revision/conversion to total knee arthroplasty was performed approximately 44 months post implantation due to unspecified complications and/or adverse events.Reportedly, the anonymized data collection activity was performed retrospectively; therefore, the information provided may be limited in detail and lack the ability for additional due diligence.As of the date of this medical investigation, patient specific medical documentation has not been provided and definitive clinical factors which could have contributed to the reported event could not be concluded.The patient impact beyond that which was reported (revision/conversion to total knee arthroplasty) could not be determined.The current health status is unknown.No further medical assessment can be rendered at this time.Devices batch number were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed devices.A review of the instructions for for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.However, based on the reported information there is no sufficient information regarding the specific reason for the conversion.A historical review concluded that there are no prior actions related to this products and events.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JUNI OX FB FEM SZ 2 RM LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16163541
• MDR Text Key: 307457481
• Report Number: 1020279-2023-00107
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627384
• UDI-Public: 03596010627384
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71422352
• Device Catalogue Number: 71422352
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 71935201 / LOT: UNKNOWN.; PN: 71935221 / LOT: UNKNOWN.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female